MAUDE Adverse Event Report: TUBING

Lot Number 13PRO1262

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2014

Event Type  Injury  

Event Description

Inappropriate saline bag filing of questionable substance.

• Brand Name: TUBING
• Type of Device: TUBING
• MDR Report Key: 3792891
• MDR Text Key: 4369036
• Report Number: 3792891
• Device Sequence Number: 3
• Product Code: FJK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2014
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 13PRO1262
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2014
• Distributor Facility Aware Date: 03/26/2014
• Event Location: Outpatient Treatment Facility
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 87